Patient–reported outcomes – an approach and application in amniotic membrane transplantation
Scripta Scientifica Salutis Publicae
Patient-reported outcomes (PROs) are a comparatively novel concept in medicine and in public health services evaluation. It relies on the fact that medical technologies are not able to give all the information about the treatment or a medical condition. Some essential data can be obtained only from the patient. Herewith, the PROs approach is presented in relation to amniotic membrane transplantation (AMT) which is applied to patients who have been treated at Varna Specialized Eye Hospital for
... Eye Hospital for different severe anterior ocular surface diseases (AOSDs). The aim of the study is to present the PROs approach and the created especially for the study Patient-Reported Outcome Measures (PROMs) tool. Further on, we aim to summarize, analyze and discuss the PROsdata of the study. MATERIALS AND METHODS: The presented PROs study enrolls 306 hospitalized patients diagnosed in seven cohorts and suitable for AMT for a period of seven years (2010-2016). It is a part of a wider research project. Demographic data and disease-related characteristics were collected in addition to the PROMs questionnaire. The PROMs instrument consists of 4 domains/questions, and the possible answers are arranged in ordinal scales. The first domain is Pain, and the possible answers are 5 (0 -none; 1 -sometimes low; 2always low; 3 -moderate to severe; 4 -always severe). The second domain is Photophobia, and the possible answers are 4 (0 -none; 1 -only at strong light; 2 -at daylight; 3 -at moderate light). The third domain is Secretion and the possible answers are 4 (0 -none; 1 -watery; 2 -mucous secretion; 3 -purulent discharge). The fourth domain is Hyperemia and the possible answers following the Efron grading scale are 5 (grade 0 -normal; grade 1 -trace; grade 2 -mild; grade 3 -moderate; grade 4 -severe). RESULTS AND DISCUSSION: The AM treatment resulted in a significant reduction of the symptoms in all domains (p< 0.001). Regarding the Pain domain, in all the groups, over 60% of the patients reported improvement. More than 90% of the patients with the most severe conditions like keratitis reported improvement. The reported and analyzed results indicate that AMT has a positive impact on all the PROs domains -Pain, Photophobia, Secretion and Hyperemia, for every patient (p<0.001). This is a novel study for Bulgaria, which aims to measure the impact of AMT on PROs among a large number of patients with severe AOSDs divided into seven cohorts for seven years. AMT proved to be a surgical method for treatment of chronic, recurrent AOSDs that improve patients' subjective well-being.